Anchoring a Medical Instrument

ABSTRACT

Some embodiments of a medical anchor device include an elongate body coupled with deployable subcutaneous anchors to secure a catheter instrument (or other medical instrument) in place relative to a skin penetration point. In some circumstances, the elongate body may be in the form of catheter hub body, and the subcutaneous anchors can be deployed from the hub body by adjustment of a movable actuator. A locking member can interact with the actuator so as to retain the actuator in the deployed orientation during the medical procedure.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This is a continuation of U.S. patent application Ser. No. 12/273,864filed on Nov. 19, 2008 and entitled “Anchoring a Medical Instrument,”the contents of which are fully incorporated herein by reference.

TECHNICAL FIELD

This document relates to an anchor device, such as a device for use insecuring the position of a catheter instrument.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Following introduction into thepatient, the catheter is secured to the patient. In some commonpractices, the catheter is secured to the patient using an adhesive tapeon the skin or by suturing a catheter hub to the patient's skin.

SUMMARY

Some embodiments of a medical anchor device include a main body coupledwith deployable subcutaneous anchors to secure a catheter instrument, orother medical instrument, in place relative to a skin penetration point.In some circumstances, the main body may be in the form of catheter hubbody, and the subcutaneous anchors can be deployed from the hub body byadjustment of a movable actuator. The actuator can be adjusted relativeto the hub body so that subcutaneous anchors deploy under the skin in asubcutaneous layer proximate to a skin penetration point, e.g., theentry point of the catheter instrument or another skin opening. Alocking member can interact with the actuator so as to retain theactuator in the deployed orientation during the medical procedure. Sucha configuration can allow the anchors to remain deployed in thesubcutaneous region to secure the position of the catheter instrumentwhile also reducing the likelihood of inadvertent withdrawal of theanchors before completion of the procedure.

In particular embodiments, a system for subcutaneously anchoring acatheter instrument may include a catheter hub body that provides fluidcommunication from one or more catheter lines to a distal catheterportion that is insertable through a skin penetration point. The systemmay also include a subcutaneous anchor mechanism movably coupled to thecatheter hub body. The subcutaneous anchor mechanism may have one ormore flexible anchors that extend outwardly away from the catheter hubbody when in a deployed orientation in a subcutaneous layer proximate tothe skin penetration point. The system may further include an actuatorthat is manually adjustable relative to the catheter hub body so as toshift the flexible anchors from a non-deployed orientation to thedeployed orientation. The system may also include a locking device thatis movable relative to the actuator so as to shift from anactuator-unlocked position to an actuator-locked positioned in which thelocking device is arranged between the catheter hub body and theactuator when the flexible anchors are in the deployed orientation.

In some embodiments, a medical anchoring system may include an elongatebody that provides fluid communication from an internal lumen to adistal catheter portion that is insertable through a skin penetrationpoint. The system may also include a subcutaneous anchor mechanismmovably coupled to the elongate body. The subcutaneous anchor mechanismmay include flexible anchors that are adjustable between a non-deployedorientation in which the flexible anchors at least partially resideinside the elongate body and a deployed orientation in which theflexible anchors extend outwardly from the elongate body into asubcutaneous layer proximate to the skin penetration point. The systemmay further include an actuator including an external portion that ismovable away from the elongate body so as to shift the flexible anchorsfrom the non-deployed orientation to the deployed orientation. Also, thesystem may include a locking device that is manually movable to fit in agap between the elongate body and the external portion of the actuatorwhen the flexible anchors are in the deployed orientation.

Some embodiments can include a method of anchoring a catheterinstrument. The method may include inserting at least a portion of acatheter hub body through a skin penetration point so that a distalcatheter portion extending from the catheter hub body is advanced into ablood vessel. The method may also include adjusting an actuator to anoperative position relative to the catheter hub body so as to deploy asubcutaneous anchor mechanism in a subcutaneous layer proximate to theskin penetration point. The subcutaneous anchor mechanism may compriseone or more flexible anchors that extend outwardly from the catheter hubbody to abut an underside of a skin layer when deployed in thesubcutaneous layer. The method may further include moving a lockingdevice relative to the actuator and the catheter hub body so that thelocking device retains the actuator in the operative position.

These and other embodiments may provide one or more of the followingadvantages. First, some embodiments of an anchor system can retain acatheter instrument in an operative position relative to a skinpenetration point without necessarily requiring sutures or skinadhesives. Second, some embodiments of an anchor system can reduce thelikelihood of damage to a skin layer, such as a subcutaneous skin layer,when the anchor system is deployed to retain a catheter instrument in anoperative position relative to a skin penetration point. Third, someembodiments of an anchor system include a locking mechanism thatminimizes the likelihood of one or more of the anchors shifting to anon-deployed position without user intervention.

The details of one or more embodiments are set forth in the accompanyingdrawings and the description below. Other features, objects, andadvantages will be apparent from the description and drawings, and fromthe claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of a medical anchor system having asubcutaneous anchor mechanism, in accordance with some embodiments.

FIGS. 2-6 illustrate exemplary operations for deploying and locking thesubcutaneous anchor mechanism of the medical anchor system of FIG. 1.

FIG. 7 is another perspective view of the medical anchor system of FIG.1.

FIG. 8A is a side view of the medical anchor system of FIG. 1.

FIG. 8B is a bottom view of the medical anchor system of FIG. 1.

FIG. 9 is another perspective view of the medical anchor system of FIG.1 showing selected internal structures of the system.

FIG. 10 is a perspective view of a portion of the medical anchor systemof FIG. 1.

FIGS. 11-13 illustrate exemplary operations for deploying and lockingthe subcutaneous anchor mechanism of the medical anchor system, inaccordance with alternative embodiments.

FIGS. 14-15 are perspective views of a medical anchor system having asubcutaneous anchor mechanism, in accordance with alternativeembodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

An anchor system can hold one or more lumens in proximity to a skinpenetration site. The anchor system can include subcutaneous anchorsthat can be activated from a non-deployed configuration to a deployedposition to engage bodily tissue in a subcutaneous region under the skinand hold the anchor system in place. In some embodiments, the anchorsystem can include a main body coupled to one or more catheter lumens tothereby cooperatively hold the main body and catheter lumens in placerelative to the skin penetration site. The anchors can be retracted froma deployed configuration to a non-deployed configuration so that damageto surrounding subcutaneous tissue is minimized when the anchor systemis withdrawn from the patient's skin.

Referring to FIG. 1, some embodiments of a medical anchor system 10include an anchor device 100 and one or more catheter lines 50 a, 50 b(collectively referred to as catheter 50) (or other medical instrument)that extend though one or more working channels of the anchor device100. The anchor device 100 may include a hub body, which can be in theform of an elongate body 110, that receives at least a portion of thecatheter 50 and houses one or more subcutaneous anchors 160. Asdescribed below, the anchors 160 may be deployable such that they extendfrom the elongate body 110. The anchor device 100 includes a distal tipportion 115 that may penetrate through a skin penetration site 22 andinto a subcutaneous layer 24 adjacent to a skin portion 20. Also, theanchor device 100 includes a proximal portion 116 that can remainexternal to the skin portion 20. In this embodiment, portions of thecatheter 50 extend from the proximal portion 116 so as to allow other,external lumen-type devices (not shown in FIG. 1) to be attached to theone or more catheter lines 50 a, 50 b. The catheter 50 includes a distalcatheter portion 53 extending from the distal tip portion 115 of theelongate body 110. The distal catheter portion 53 is configured to beadvanced into a blood vessel 25 or other bodily lumen of a human oranimal patient and toward a targeted body site inside the patient'sbody. As described in more detail below, the distal catheter portion 53provides fluid communication from the one or more catheter lines 50 a,50 b to the blood vessel 25. For example, the distal catheter portion 53may include a plurality of internal lumens (e.g., coaxial or adjacent)extending toward the catheter tip 52. Thus, the catheter line 50 a maybe in fluid communication with a first internal lumen of the distalcatheter portion 53, and the second catheter line 50 b may be in fluidcommunication with a second internal lumen of the distal catheterportion 53. Alternatively, the first and second catheter lines 50 a and50 b can be in fluid communication with the same internal lumen of thedistal catheter portion 53. In other embodiments in which the hub body110 receives a single catheter line (e.g., single lumen PICC device orthe like), the hub body 110 can include a lumen that provides fluidcommunication between the single catheter line and the internal lumen ofthe distal catheter portion 53.

The anchor device 100 can be used to retain the catheter 50 near theskin penetration site 22. In particular, the elongate body 110 can housethe one or more anchors 160. As described in more detail below, theanchors 160 may comprise one or more flexible tines 160 a that aredeployable into the subcutaneous layer 24 under the skin portion 20 soas to retain the position of the anchor device 100 relative to the skinpenetration site 22.

In this embodiment, the anchor device 100 includes an actuator 141 thatadjusts the anchors 160 from a non-deployed position (FIG. 2) to thedeployed position depicted in FIG. 1. The actuator 141 may operate as asliding mechanism that reciprocates along a portion of the catheterlines 50 a and 50 b near the elongate body 110. As discussed in greaterdetail below, a portion of the actuator 141 includes an actuator rod 164(FIG. 10) that deploys and retracts the anchors 160 by reciprocatingalong an interior actuator channel 169 (FIG. 7) of the elongate body 110between a distal position and a proximal position. A user may insert theelongate body 110 through the skin penetration site 22 so that one ormore anchor deployment ports 165 (FIG. 9) are arranged under the skinportion 20 in the subcutaneous layer 24. For example, the anchor device100 may penetrate the skin portion 20 through a small incision made by aphysician. In some cases a dilation instrument (not shown in FIG. 1) maybe used to assist in advancing the anchor device 100 through theincision. During insertion, the anchors 160 are in the non-deployedposition, being substantially encased within the anchor device 100. Theanchors can be placed in the non-deployed position by shifting theactuator 141 to a distal position, where the actuator 141 is moved awayfrom the elongate body 110. After insertion, the distal catheter portion53 and possibly the distal tip portion 115 of the elongate body 110 canbe advanced into a targeted blood vessel 25 or other body lumen. Whenthe anchor device 100 is arranged in the desired position, the user canapply a force to the actuator 141 so as to slide the actuator 141 fromthe distal position to a proximal position (refer to FIGS. 2-3). Asdescribed in more detail below, the adjustment of the actuator 141causes the flexible tines 160 a to shift from a non-deployed position tothe deployed position shown in FIG. 1. Also described in more detailbelow, the actuator 141 can be secured in the proximal position using alock 140 that is movably connected to the actuator 141 (e.g., pivotsabout a pivot member 143 in this embodiment). The lock 140 can minimizethe likelihood of the anchors 160 inadvertently retracting to anon-deployed position until the anchor device 100 is ready to bewithdrawn from the subcutaneous layer 24.

Still referring to FIG. 1, in some embodiments, one or more flowrestriction devices 52 a, 52 b can control fluid flow through thecatheter 50. In this embodiment, each flow restriction device 52 a, 52 bincludes a resiliently flexible member 52 f configured to compress uponan associated catheter line 50 a or 50 b. The flow restriction devices52 a, 52 b can include one or more ports 52 h through which catheterline 50 a can pass such that the flow restriction device 52 a, 52 b areslidable along a length of the catheter 50 when in an unlockedconfiguration. In this embodiment, the resiliently flexible member 52 fincludes one or more opposing protrusions 52 d, 52 e which exert asqueezing force on the catheter 50 when the resiliently flexible member52 f is compressed upon the catheter 50. Fluid flow through the cathetercan be adjusted by applying a requisite pressure to the catheter via theopposing protrusions 52 d, 52 e. A locking mechanism 52 g can hold therelative position of the opposing protrusions 52 d, 52 e in a chosenposition so that a chosen level of fluid flow can be maintained over aperiod of time without further user intervention.

In some cases, the proximal ends of catheter lines 50 a, 50 b eachterminate into a catheter coupling member 51 a, 51 b (collectivelyreferred to as coupling member 51) respectively. The catheter couplingmember 51 can be used to connect one or more of the catheter lines 50 a,50 b to another catheter (not shown) or another type of medical devicehaving a lumen, including a pump system. Catheter coupling members 51 a,51 b can permit a range of fluid delivery and sampling systems to beconnected to the medical device anchor system 10 without necessarilyrequiring a new anchoring system to be inserted into the patient eachtime. Such a configuration can be useful for patients who receive a PICCline for infusion of various medications or withdrawing bodily fluids(without repeated insertion of syringe needles into the patient).

Still referring to FIG. 1, the anchor device 100 includes the anchors160 for use in the temporary anchoring of at least a portion of elongatebody 110 in the subcutaneous layer 24 under the skin portion 20. In someembodiments, the anchors 160 may comprise a material that exhibitssuperelasticity. As such, the anchors 160 can flexibly shift from anon-deployed position (FIG. 2) to a deployed position (FIG. 1) when inthe subcutaneous layer 24 of the skin portion 20. For example, theanchors 160 may be formed from a length of nitinol wire or from a sheetof nitinol material, which has been processed to exhibit superelasticitybelow or at about a normal human body temperature, such as below or atabout 37 degrees Celsius. The nitinol material may comprise, forexample, Nickel Titanium (NiTi), Niobium Titanium (NbTi), or the like.Alternatively, the anchors 160 may comprise a metal material such asstainless steel, spring steel, titanium, MP35N and other cobalt alloys,or the like. In these embodiments, the anchors 160 can be formed from amaterial or materials that allow them to be adjustable from thenon-deployed position to the deployed position as shown in FIG. 1.

In some embodiments, the anchors 160 can be flexed to a stressedcondition when in the non-deployed position, e.g., prior to placement ofthe anchor device 100 in a patient. For example, as described below inconnection with FIG. 2, the anchors 160 may be retracted into aninternal space of the elongate body 110 when in the non-deployedposition. When deployed, as shown in FIG. 1, the anchors 160 can returntoward a shape (e.g., by exhibiting superelastic characteristics) thatallow the anchors 160 to secure the elongate body 110 relative to theskin penetration site 22 for a period of time until the treatment withthe catheters 50 is completed.

The anchors 160 may be designed with a curvature that facilitates thetransition from the non-deployed to the deployed position. Furthermore,the curvature of the anchors 160 may be configured to eliminate orreduce the potential damage to the skin during deployment of the anchors160. For example, the anchors 160 may include a convex curvature thatabuts against the underside of the skin portion 20 in a manner thatprevents the flexible tines 160 from piercing through the underside ofthe skin portion 20. When the anchors 160 extend from the anchordeployment ports 165 (refer to FIGS. 7-9) positioned in the subcutaneouslayer 24, the curved shape of the anchors 160 can allow them to deployadjacent to the skin portion 20 while reducing the likelihood of tearingor otherwise damaging the skin portion 20. When deployed, the anchors160 can serve to retain the elongate body 110 of the anchor device 100relative to the skin penetration site 22. In some embodiments, theanchors 160 may provide a holding force of about 1 lb. or greater,depending upon the medical procedure being performed, the materialscomprising the anchors 160, the geometry of the anchors 160, and/orother factors. For example, the anchors 160 may provide a holding forceof about 0.5 lbs or more, about 1 lb to about 20 lbs, about 1 lb toabout 5 lbs, or about 2 lbs to about 3 lbs.

In use, the anchors 160 can be shifted to the non-deployed position(refer, for example, to FIG. 2) prior to insertion so as to minimizeresistance and possible damage to the skin portion 20 when a portion ofelongate body 110 is inserted through the skin penetration site 22. Insome cases, the medical device anchor system 10 can be shipped to theintended user (e.g., a physician or other healthcare provider), with theanchors 160 in the non-deployed position, so that the anchor device 100can be readily inserted into the skin portion 20 without necessarilyrequiring the user to shift the actuator 141. When the anchor device 100has been inserted to the intended depth inside the subcutaneous layer24, the anchors 160 can be shifted to the deployed position (refer, forexample, to FIG. 1) to provide at least temporary anchoring for theanchor device 100. When removal of the anchor device 100 is desired, theanchors 160 can be shifted back to the non-deployed position (e.g., byadjustment of the actuator 141) to reduce the likelihood of withdrawalresistance and possible damage to the skin portion 20 during removal.

Referring now to FIGS. 2-6, some embodiments of the medical deviceanchor system 10 can be configured with the lock 140 movably coupled tothe actuator 141 (e.g., rotatably coupled about the pivot member 143 inthis embodiment). The lock 140 can be used to secure the actuator 141 ina selected configuration such that the anchors 160 remain in thedeployed position. Referring to FIG. 2, the anchor device 100 is in anon-deployed and non-locked configuration. In particular, the anchors160 are retained inside an internal space of the elongate body 110 in anon-deployed position. The elongate body 110 can include the anchordeployment ports 165 (FIG. 7) through which the anchors can be extendedand retracted in response to movement of the actuator 141. In thisconfiguration, the actuator 141 is arranged in a distal position (FIG.2) before it is slidably adjusted in a longitudinal direction 190 to aproximal position (FIG. 3). Also in this configuration, the lock 140 isarranged in a first rotational position in which it is positionedproximal to the actuator 141.

When the anchor device 100 is in the non-deployed and non-lockedconfiguration (FIG. 2), the distal tip portion 115 of the elongate body110 can be readily inserted through the skin penetration site 22 (referto FIG. 1) without interference from the anchors 160. In a preferredembodiment, the catheter 50 is fixedly coupled to the elongate body 110as described in greater detail below. As such, the catheters lines 50 a,50 b can remain affixed to the elongate body 110 during the time thatthe elongate body 110 remains anchored to the skin portion 20, andvarious other fluid supplying or sampling lumens can be connected viathe catheter coupling members 51 a, 51 b. In alternative embodiments,the anchor device 100 may act as a sleeve so that the elongate body 110has a channel to releasably receive a separate catheter or instrumentafter the sleeve is seated at the skin penetration site 22.

Referring now to FIG. 3, the anchor device 100 can be adjusted to adeployed and non-locked configuration. In this configuration, theanchors 160 are deployed from their respective anchor deployment ports165 (FIG. 7) so as to extend outwardly from the elongate body 110 of theanchor device 100. In particular, the anchors 160 are shifted to thedeployed position when the actuator 141 is moved in the longitudinaldirection 190 to the proximal position. The actuator 141 can be pulledby a user to slide the actuator 141 toward the proximal position. Themovement of the actuator 141 transmits a deployment force to the anchors160 via the actuator rod 164 (FIG. 10), so that the anchors 160 at leastpartially extend out of the anchor deployment ports 165. As previouslydescribed, the flexible tines 160 a can include a curved shape thatfacilitates the transition from the non-deployed to the deployedposition and reduces the likelihood of damaging the underside of theskin portion 20 during deployment in the subcutaneous layer 24 (FIG. 1).Anchor tines 160 a may be disposed proximal to the anchor deploymentports 165 such that when the actuator rod 164 is drawn rearward (e.g.,opposite the direction of the distal tip 115), a force is imparted tothe anchor 160 which forces them to protrude from the anchor deploymentports 165.

Referring now to FIGS. 4-6, the anchor device 100 can be adjusted fromthe deployed and non-locked configuration (FIG. 3) to a deployed andlocked configuration (FIG. 6). The anchor device 100 can first beshifted to the deployed and non-locked configuration (as previouslydescribed in connection with FIG. 3). Lock 140 may be employed to hinderthe actuator 141 from prematurely shifting back toward the distalposition (FIG. 2), which might otherwise cause the anchors 160 toprematurely retract. In some embodiments, the lock 140 can provide amechanical bracing force between the actuator 141 and a proximal surface131 of the elongate body 110 that reduces the likelihood of the actuator141 prematurely shifting to the distal position without userintervention. In this embodiment, lock 140 is coupled to a swing arm 142that allows rotational pivoting of the lock 140 about the pivot member143. The pivot member 143 can include an elongate shaft that extendsthrough an aperture of the swing arm 142 to rotatably couple the swingarm 142 and the actuator 141. The pivot member 143 can include an endcap or retainer head so as to permit the swing arm 142 and the actuator141 to be rotatably coupled while reducing the likelihood of separation.

In this embodiment, the lock 140 and the swing arm 142 are made of aresiliently flexible material. For example, the lock 140 and the swingarm 142 can be integrally molded from a flexible polymer material. Thelock 140 has curved portions 140 a, 140 b that substantially mate withan outer circumference of catheter lines 50 a and 50 b, respectively.The curved portions 140 a, 140 b circumferentially engage catheter lines50 a and 50 b when in a locked configuration, thus reducing thelikelihood of the lock 140 rotationally shifting from the proximal ordistal position without user intervention. Because the lock 140 is madefrom a flexible material, curved portions 140 a, 140 b can flexoutwardly when engaging or disengaging the lock 140 to or from thecatheter lines 50 a, 50 b. Lock 140 can resiliently return to itsoriginal form after being flexed outwardly to either to remove or engagethe lock 140 with the catheter lines 50 a, 50 b. Swing arm 142 issimilarly resiliently flexible to allow the engagement and disengagementof the lock 140 with the catheter lines 50 a, 50 b. In this embodiment,swing arm 142 can flex from a substantially planar configuration whenthe lock 140 is engaged with catheter lines 50 a, 50 b (FIG. 1), to acurved configuration when the lock 140 is disengaged from the catheterlines 50 a, 50 b (FIG. 11).

As shown in FIG. 4, the anchor device 100 can be adjusted from thedeployed and non-locked configuration (FIG. 3) to a deployed and lockedconfiguration (FIG. 6) by first disengaging the lock 140 from catheterlines 50 a, 50 b while the lock 140 is in the proximal position. Thismay be accomplished by, e.g., exerting the requisite force (e.g., anupward force) on the lock 140 so that the curved portions 140 a, 140 bshift away from the catheter lines 50 a, 50 b. At this point the lock140 and the swing arm 142 can rotate about the pivot member 143 so thatthe lock 140 is moved in a rotational direction 191.

As shown in FIG. 5, the lock 140 can be further moved by angularrotation 192 to place the lock 140 and the swing arm 142 in anintermediate distal position. As the lock 140 is being rotated from afully proximal position (FIG. 3) to a fully distal position (FIG. 6),the position of the actuator 141 can remain substantially stationaryrelative to the elongate body 110, thus maintaining the deployedposition of the anchors 160.

As shown in FIG. 6, when the lock 140 approaches the fully distalposition (as denoted by angular rotation 193), the swing arm 142 and thelock 140 can be lifted slightly, allowing the curved portions 140 a, 140b of the lock 140 to transition over the catheter lines 50 a, 50 b untilthe longitudinal axis of the swing arm 142 is substantially parallelwith the longitudinal axis of the elongate body 110. A force can beapplied to the swing arm 142 and the lock 140 so that the lock 140 snapsdown and engages the catheter lines 50 a, 50 b in a locked configuration(FIG. 6). Once in the distal and locked position (FIG. 6), the lock 140mates with the proximal surface 131 of the elongate body 110 so as tofit snugly between the elongate body 110 and the actuator 141. Thisconfiguration can reduce the likelihood of the actuator 141 prematurelyshifting to a distal position (and premature withdrawal of the anchors160).

In this embodiment, when the anchor device 100 is in a deployed andlocked configuration (FIG. 6), various fluid delivery and samplingsystems can be coupled with the medical device anchor system 10. Forexample, blood may be drawn from the catheter lines 50 a, 50 b;likewise, medications can be introduced into a patient's blood vessel 25via the one or more catheter lines 50 a, 50 b. The medical device anchorsystem 10 may remain attached to the skin for an extended period ofdays, weeks, or months.

To remove the anchor device 100 from the patient, the process describedfor inserting the anchor device 100 (refer to FIGS. 2-6) described abovecan generally be reversed. For example, in this embodiment, to removethe anchor device 100 from the skin portion 20, the lock 140 can belifted so as to disengage the catheter lines 50 a, 50 b. The lock 140and swing arm 142 thus become free to rotate about the pivot member 143as previously described. The lock 140 can be rotated from a distalposition (FIG. 6) to a proximal position (FIG. 3). The user may chooseto re-engage the lock 140 in the proximal position with the catheterlines 50 a, 50 b, however this step may be unnecessary if the usersimply wishes to withdraw the anchor device 100 from the skin portion20. With the lock 140 in a proximal position, the actuator 141 is freeto shift from the proximal position to a distal position (FIG. 2), whichhas the effect of applying a translational force to the actuator rod 164(FIG. 10).

Referring to FIG. 7, as the actuator rod 164 slides forward inside of anactuator channel 169, the anchors 160 are retracted through the anchordeployment ports 165 and into the anchor device 100. In this embodiment,when an anchor tip portion 162 (FIG. 10) abuts a distal end 166 of theactuator channel 169, the anchors 160 become substantially encasedwithin the anchor device 100. With the anchors 160 in the non-deployedconfiguration, the anchor device 100 may be withdrawn from the skinportion 20 by grasping a gripping portion 130 of the elongate body 110and providing a withdrawing force. The likelihood of damaging the skinportion 20 can be reduced when the anchor device 100 is removed becausethe anchors 160 are arranged in the non-deployed configuration.

Referring now to FIGS. 7-10, the adjustment of the actuator 141 cancause one or more internal structures to move within the anchor device100. For example, in this embodiment, the actuator 141 can be adjustedto cause the actuator rod 164 (FIG. 10) to move within the actuatorchannel 169. As shown in FIG. 7, the anchor device 100 can be arrangedin the deployed and locked configuration so that the anchors 160 extendfrom an internal space within the elongate body 110 (as previouslydescribed in connection with FIG. 1). The elongate body 110 of theanchor device 100 can be made of a biocompatible material, such as PEEK(polyetheretherketone), polyethylene, polyimide, or the like. Theelongate body 110 may include a tapered portion 134 along the distal tipportion 115 that facilitates insertion of the anchor device 100 throughthe skin penetration site 22. In this embodiment, the gripping portion130 of the anchor device 100 includes a mesa 170 that forms an insertionstop, which may be used to inhibit insertion of the elongate body 110into the skin portion 20 beyond a particular depth (so that the anchorports 165 reside in the subcutaneous layer 24). In practice, as theelongate body 110 is advanced into the skin portion 20, a mesa wall 171can abut a skin portion 20 surface when the elongate body 110 has beeninserted substantially the appropriate distance to allow the anchors 160to be deployed in the subcutaneous layer 24. In some embodiments, themesa 170 can provide a surface onto which information about the medicaldevice anchor system 10 can be indicated.

Referring now to FIGS. 8A, 8B, and 9, in some embodiments, the elongatebody 110 can include one or more internal lumens 132 a, 132 b. Thelumens 132 a, 132 b can be configured for fluid communication withcatheter lines 50 a, 50 b or other medical instruments to allowtransport of fluids from the catheter coupling members 51 a, 51 b to thedistal catheter portion 53 (FIG. 1). In some implementations, internallumens 132 a, 132 b are integral portions of catheter lines 50 a, 50 bthat extend into the elongate body 110. In other implementations, theinternal lumens 132 a, 132 b can be separate lumens, and a connectioninterface joins the internal lumens 132 a, 132 b with catheter lines 50a, 50 b. In this embodiment, internal lumens 132 a, 132 b extend throughthe elongate body 110 and transition to a side-by-side position in thedistal tip portion 115. After insertion of at least a portion of theelongate body 110 into the subcutaneous region 24 (FIG. 1), the internallumens 132 a, 132 b can be used to introduce or sample fluids into orfrom a patient in cooperation with the distal catheter portion 53. Inthis embodiment, the distal catheter portion 53 includes two channels137 a, 137 b (FIG. 9), each of which is coupled to a distal end of aninternal lumen 132 a, 132 b respectively, thereby allowing fluidcommunication between the blood vessel 25 (FIG. 1), the distal catheterportion 53, the internal lumens 132 a, 132 b, and catheter lines 50 a,50 b.

In some embodiments, the internal lumens 132 a, 132 b can have adiameter of about 3 French to about 30 French, and about 5 French toabout 20 French, including particular ranges from about 3 French toabout 7 French and about 12 French to about 17 French. In alternativeembodiments of the anchor device 100, each internal lumen 132 a, 132 bcan have a different shape or size. Furthermore, the multiple internallumens 132 a, 132 b may be selectively sealable so that one internallumen could be accessed while another is sealed. In some embodiments,this functionality can be achieved using the flow restriction devices 52a, 52 b as described in relation to FIG. 1.

Referring to FIGS. 7-9, the anchor device 100 includes the actuatorchannel 169 and the ports 165 to facilitate the actuation of the anchors160. The actuator channel 169 can be formed in the elongate body and iscapable of receiving the actuator rod 164. The actuator channel 169 maybe defined at least partially by one or more surfaces that can slidablyengage the actuator rod 164 and anchors 160. Movement of the actuatorrod 164 within the actuator channel 169 can urge the anchors 160 toextend from, or retract into, the anchor deployment ports 165. In thisembodiment the actuator channel 169 may have a polygonal cross-sectionalshape (e.g., quadrilateral or the like) that permits longitudinalmovement of the actuator rod 164 while hindering possible rotationalmovement of the actuator rod 164 about its longitudinal axis.

The actuator channel 169 in this embodiment includes a distal portionnear the distal tip portion 115 within the elongate body 110 thataccepts a tip portion 162 of the actuator rod and at least a portion ofthe anchors 160 when the anchor device 100 is arranged in thenon-deployed configuration. In this embodiment, when the tip portion 162approaches the distal portion of the actuator channel 169, the anchors160 approach the fully retracted (non-deployed) configuration and do notsubstantially extend from the anchor deployment ports 165. The actuatorchannel 169 and the internal lumens 132 a, 132 b may extendlongitudinally along the elongate body 110 in a side-by-sideconfiguration.

Referring now to FIG. 10, the actuator rod 164 may include an actuatorshaft 164 a that can be advanced and retracted within the actuatorchannel 169 in response to the movement of the actuator 141. In thisembodiment, the anchors 160 are coupled to the actuator shaft 164 athrough a reduced portion 164 b that is sized to fit adjacently betweenthe anchors 160 in the distal portion of the actuator channel 169.Movement of the actuator 141 (and the corresponding translation of theactuator rod 164 within the actuator channel 169) causes the anchors 160to shift between the non-deployed position (FIG. 2) and the deployedposition (FIG. 3).

Referring back to FIGS. 7-9, in some cases, the actuator channel 169 maynot fully extend through the elongate body 110 of the anchor device 100.For example, the actuator channel 169 may extend distally to a depththat extends to a terminal end (e.g., distal end 166) (FIG. 8A). In someembodiments, when the actuator 141 is shifted to the distal position(FIG. 2), the actuator rod 164 is caused to distally advance within theactuator channel 169 such that the tip portion 162 of the actuator rod164 approaches the distal end 166 of the actuator channel 169, but maynot abut the distal end 166. In this embodiment, the anchors 160 arecoupled to the actuator rod 164 near the tip portion 162 so that theanchors 160 retract into the elongate body 110 as the anchor tip portion162 of the actuator rod 164 approaches the distal end 166 of theactuator channel 169. In such circumstances, the anchors 160 may beflexed to a stressed condition while being retained within the actuatorchannel 169 or other internal space of the elongate body 110.

The actuator 141 can be adjusted to generate a longitudinal movement(e.g., longitudinal movement 190 (FIG. 3)), which is translated to theactuator rod 164 via a connector portion 167 (FIG. 10). In suchcircumstances, the actuator rod 164 may slide within the actuatorchannel 169 so that the tip portion 162 of the actuator rod 164 shiftsaway from the distal end 166 of the actuator channel 169. This motion ofthe actuator rod 164 causes the tips of the anchors 160 to pass throughthe anchor deployment ports 165 and to extend outwardly from theelongate body 110.

Referring again to FIG. 10, in some cases the actuator rod 164 can becoupled to the actuator 141 via a support shaft 197. For example, thesupport shaft 197 can be coupled to actuator rod 164 using anovermolding process. In this embodiment, the actuator 141 providessupport for a support shaft 197 as well as the swing arm 142 asdescribed below. The actuator 141 in this embodiment includes catheterline supports 168 a and 168 b to support portions of the catheter lines50 a and 50 b.

Accordingly, in this embodiment, the actuator rod 164 and the actuator141 can be coupled so that the movement 135 of the actuator 141 resultsin a corresponding movement of the actuator rod 164. The connection canbe configured to transmit longitudinal forces from the actuator 141 tothe actuator rod 164, thereby directing the anchors 160 to extend fromor retract into the elongate body 110 as previously described. Theanchors 160 can be integrally formed with the actuator rod 164 (e.g.,formed from a nitinol material or the like). It should be understoodfrom the description herein that, in some embodiments, the anchors 160can be joined with the actuator rod 164 at a location other than at thetip portion 162. For example, in other embodiments, the anchors 160 maybe connected to the actuator rod 164 along a middle region of theactuator rod 164. Also, in alternative embodiments, the anchors 160 maybe non-integral with the actuator rod 164. For example, the anchors 160may be formed separately from the actuator rod 164 and then mounted tothe actuator rod 164 using adhesives, welds, connectors, or the like.

Referring now to FIGS. 11-13, in an alternative embodiment, the anchordevice 100 can be adjusted from a non-deployed and non-lockedconfiguration (FIG. 11) to a deployed and locked configuration (FIG. 13)without necessarily rotating the lock 140. In this embodiment, theactuator 141 slidably engages the catheter lines 50 a, 50 b and iscoupled to the actuator rod 164 (FIG. 10), similar topreviously-described embodiments. Deployable anchors 160 extendoutwardly from the elongate body 110 when the actuator 141 is moved bylinear translation 194 from a distal position (FIG. 11) to a proximalposition (FIGS. 12 and 13). In this embodiment, when the actuator 141 isshifted from the distal position (FIG. 11) to the proximal position(FIG. 13), the anchors 160 deploy outwardly from ports 165. Similar topreviously-described embodiments, the lock 140 provides a mechanism toprevent the actuator 141 from prematurely shifting from the proximalposition to the distal position, which may then retract the anchors 160.

In this embodiment, the arm 142 is made from a resiliently flexiblematerial that allows it to bend between a generally planar configuration(FIGS. 11 and 13) and a curved configuration (FIG. 12). When theactuator 141 is in the distal position (FIG. 11) the arm 142 becomesflexed such that the lock 140 correspondingly shifts to a positionadjacent to an outer surface of the elongate body 110. When the actuator141 is shifted to the proximal position (FIG. 13) the lock 140 cancorrespondingly shift to a proximal position that allows the lock 140 toengage with the catheter lines 50 a, 50 b as previously described andshown in FIG. 13. As such, the lock 140 can fit snugly between theactuator 140 and the elongate body 110 to retain the actuator 141 in theactive position. When the actuator 141 is shifted to the proximalposition (FIG. 13), the anchors 160 are deployed as previouslydescribed. In this embodiment, the arm 142 may not necessarily rotateabout a pivot pin, and instead may be fastened to the actuator 141 toallow it to be shifted between a generally planar and a curved ornon-planar configuration. In some cases, the arm 142 can be riveted inplace to reduce the likelihood inadvertent rotation.

Accordingly, the user can readily deploy the anchors 160 into thesubcutaneous layer 24 of the skin portion 20 by adjusting the actuator141 and snapping the lock 140 into position. For example, a physicianmay advance the anchor device 100 into the skin portion 20 and deliverthe distal catheter portion 53 in a targeted blood vessel 25. Then thephysician can, for example, grasp the gripping portion 130 of theelongate body 110 while sliding the actuator 141 from the distal (FIG.11) to the proximal (FIG. 13) position, thereby deploying the anchors160 into the subcutaneous layer 24. The physician may contemporaneouslyexert a pressing force on the arm 142 (and the lock 140) so as to snapthe lock 140 down upon the catheter lines 50 a, 50 b to reduce thelikelihood of prematurely moving the actuator 141 and retracting theanchors 160.

Referring now to FIGS. 14-15, some alternative embodiments of an anchordevice 200 can include a lock 240 that is movably attached to a catheterhub body (e.g., the elongate body 110 in the depicted embodiment). Assuch, the lock 240 can be readily adjusted relative to the actuator 241so as to retain the actuator 241 in a deployed and locked configuration(FIG. 15). For example, the user may grasp the actuator 241 with his orher fingers to pull in a longitudinal path 294 while readily pushing thelock 240 with his or her thumb in a downward motion 295. Accordingly,the lock 240 can be arranged between the catheter hub body (e.g.,elongate body 110 in this embodiment) and the actuator 241 when theflexible anchors 160 are deployed in the subcutaneous layer 24. In suchcircumstances, the lock 240 can reduce the likelihood of the actuator241 prematurely shifting from the proximal position to the distalposition to thereby inadvertently retract the anchors 160.

Similar to previously described embodiments, the anchor device 200 mayinclude a number of catheter lines 50 a, 50 b that extend from cathetercoupling members 51 a, 51 b toward the elongate body 110. The elongatebody 110 can provide fluid communication between the catheter lines 50a, 50 b and the distal catheter portion 53 that is delivered into atargeted body vessel 25. Also similar to previously describedembodiments, the actuator 241 of the anchor device 200 can be coupled tothe actuator rod 164 (FIG. 10) so as to deploy anchors 160 in thesubcutaneous layer 24 when the elongate body 110 is passed into the skinpenetration point 22. As previously described, the anchors 160 extendoutwardly from the elongate body 110 when deployed from the ports 165into the subcutaneous layer 24.

Still referring to FIGS. 14-15, the anchor device 200 can be adjustedfrom the deployed and non-locked configuration (FIG. 14) to a deployedand locked configuration (FIG. 15). In some embodiments, the lock 240can provide a mechanical bracing force between the actuator 241 and aproximal surface of the elongate body 110 to thereby retain the actuator241 in the active or deployed position (FIG. 15) throughout the medicalprocedure. In this embodiment, lock 240 is coupled to an arm 242 that isattached to the elongate body 110 at a connection point 243. The arm 242can comprise a resiliently flexible material that allows it to bend toand from a generally planar configuration (FIG. 14). For example, thelock 240 and the swing arm 242 can be integrally molded from a flexiblepolymer material. The lock 240 may include curved portions thatsubstantially mate with an outer circumference of catheter lines 50 a-b,thus reducing the likelihood of the lock 240 rotationally shifting fromthe locked position without user intervention. When the actuator 241 isin the distal position (FIG. 14), the arm 242 can be flexed or otherwisemanipulated such that the lock 240 correspondingly shifts to a positionadjacent to an outer surface of the actuator 241. When the actuator 241is shifted to the proximal position (FIG. 15), the lock 240 cancorrespondingly shift to an intermediate position between the elongatebody 110 and the actuator 241. As such, the lock 240 can fit snuglybetween the actuator 241 and the elongate body 110 to retain theactuator 241 in the active position, which causes the anchors 160 toremain deployed as previously described. The arm 243 may pivot relativeto the elongate body 110 about the connection point 243. Alternatively,the arm 242 may instead be fixed to the elongate body so that it canflexibly adjust between a generally planar and a non-planarconfiguration.

The anchor device 200 can be adjusted from the non-deployed andnon-locked configuration (FIG. 14) to a deployed and lockedconfiguration (FIG. 15) by first disengaging the lock 140 from catheterlines 50 a, 50 b while the lock 140 is in the proximal position. Thismay be accomplished, for example, by moving the actuator 241 in alongitudinal path 294 away from the elongate body 110 so that theanchors 160 are deployed into the subcutaneous layer 24. When theactuator 241 is moved in the longitudinal path 294 away from theelongate body, a gap is created therebetween. As such, the lock 240 canbe pressed in a downward path 295 (or a pivoting path) into the spacebetween the actuator 241 and the elongate body 110 so as to fit snuglybetween the elongate body 110 and the actuator 241. As such, the lock240 retains the actuator 241 in a substantially stationary positionrelative to the elongate body 110, thereby maintaining the deployedposition of the anchors 160. This configuration can reduce thelikelihood of the actuator 241 prematurely shifting to a distal position(and premature withdrawal of the anchors 160).

In this embodiment, when the anchor device 200 is in a deployed andlocked configuration (FIG. 15), various fluid delivery and samplingsystems can be coupled with the anchor device 200. For example, bloodmay be drawn from the catheter lines 50 a, 50 b; likewise, medicationscan be introduced into a patient's blood vessel 25 via the one or morecatheter lines 50 a, 50 b and the distal catheter portion 53. The anchordevice 200 may remain attached to the patient for an extended period ofdays, weeks, or months.

To remove the anchor device 200 from the skin, the process described forinserting the anchor device 200 (refer to FIGS. 14-15) can generally bereversed. For example, in this embodiment, to remove the anchor device200 from the skin, the lock 240 can be lifted so as to disengage theactuator 241. With the lock 140 in a disengaged position, the actuator241 is free to shift from the proximal position to the distal position(FIG. 14), which has the effect of applying a translational force to theinternal actuator rod 164 (FIG. 10) and retracting the anchors 160 intothe ports 165. Thereafter, the anchor device 200 can be safely withdrawnfrom the skin in a manner that reduces the likelihood of trauma to thesurrounding tissue.

A number of embodiments have been described. Nevertheless, it will beunderstood that various modifications may be made without departing fromthe spirit and scope of the disclosed embodiments. Accordingly, otherembodiments are within the scope of the following claims.

1. A system for subcutaneously anchoring a catheter instrument,comprising: a catheter hub body that connected to first and secondproximal external lines and connected to a distal catheter line which isinsertable through a skin penetration point, wherein the catheter hubbody provides fluid communication between the first proximal externalline and a first lumen of the distal catheter line and provides fluidcommunication between the second proximal external line and a secondlumen of the distal catheter line; a pair of subcutaneous anchorelements that are adjustable between a non-deployed orientation in whichthe subcutaneous anchor elements are housed inside the catheter hub bodyand a deployed orientation in which free ends of the subcutaneous anchorelements extend outwardly away from the catheter hub body in asubcutaneous layer proximate to the skin penetration point; an actuatorto shift the flexible anchors from the non-deployed orientation to thedeployed orientation; and a locking device to releasably maintain thepair of subcutaneous anchor elements in the deployed orientation,wherein the first and second proximal external lines, at least a portionof the actuator, and the locking device are configured to remainexternal to the skin penetration point when the distal catheter line andthe pair of subcutaneous anchor elements are inserted through the skinpenetration point.
 2. The system of claim 1, wherein the catheter hubbody has a greater lateral width at a proximal end than at a distal end,wherein the first and second proximal external lines are connected tothe proximal end of the catheter hub body in a generally side-by-sideposition, wherein the distal catheter line is connected to the distalend of the catheter hub body, and wherein the pair of subcutaneousanchor elements are positioned between the proximal end and the distalend of the catheter hub body.
 3. The system of claim 1, wherein thefirst proximal external line comprises a first catheter coupling memberat a proximal end of the first proximal external line, wherein thesecond proximal external line comprises a second catheter couplingmember at a proximal end of the second proximal external line, andwherein each of the first and second proximal external line isconfigured to releasably connect with a medical device.
 4. The system ofclaim 1, wherein the actuator includes an actuator rod that extendsthrough an actuator channel defined inside the catheter hub body andthat is coupled with the anchor elements.
 5. The anchor device of claim4, wherein the actuator comprises a slider instrument that reciprocatesalong a portion of the first and second proximal external lines at alocation proximal of a proximal end of the catheter hub body.
 6. Thesystem of claim 5, wherein the locking device is movably connected tothe slider instrument of the actuator.
 7. The system of claim 1, whereineach of the anchor elements extend from the catheter hub body in ancurved manner when in the deployed orientation, and wherein each of theanchor elements extends to a rounded tip
 8. The system of claim 11,wherein at least a portion of each anchor element exhibitssuperelasticity when shifted from the non-deployed orientation to thedeployed orientation.
 9. The system of claim 1, wherein when the lockingdevice is shifted to an actuator-locked position, the locking devicelimits movement of the actuator relative to the catheter hub body andhinders migration the flexible anchors from the deployed position towardthe non-deployed position.
 10. The system of claim 9, wherein thelocking device is friction fit between a proximal end of the catheterhub body and a distal facing surface of the actuator when the lockingdevice is shifted to the actuator-locked position.
 11. A system forsubcutaneously anchoring a catheter instrument, comprising: a catheterhub body that is connected to first and second proximal external linesand connected to a distal catheter line which is insertable through askin penetration point, wherein the first and second proximal externallines are connected to a proximal end of the catheter hub body in agenerally side-by-side position, and wherein the catheter hub bodyprovides fluid communication between the first proximal external lineand a first lumen of the distal catheter line and provides fluidcommunication between the second proximal external line and a secondlumen of the distal catheter line; and a pair of subcutaneous anchorelements that are adjustable between a non-deployed orientation and adeployed orientation in which free ends of the subcutaneous anchorelements extend laterally outward from the catheter hub body in asubcutaneous layer proximate to the skin penetration point, wherein thesubcutaneous anchor elements are flexible and the free ends of thesubcutaneous anchor elements comprises rounded tips, wherein the firstand second proximal external lines and at least a proximal portion ofthe catheter hub body are configured to remain external to the skinpenetration point when the distal catheter line and the pair ofsubcutaneous anchor elements are inserted through the skin penetrationpoint.
 12. The system of claim 11, wherein the catheter hub body has agreater lateral width at the proximal end than at a distal end, whereinthe distal catheter line is connected to the distal end of the catheterhub body, and wherein the pair of subcutaneous anchor elements arepositioned between the proximal end and the distal end of the catheterhub body.
 13. The system of claim 12, wherein the first proximalexternal line comprises a first catheter coupling member at a proximalend of the first proximal external line, wherein the second proximalexternal line comprises a second catheter coupling member at a proximalend of the second proximal external line, and wherein each of the firstand second proximal external line is configured to releasably connectwith a medical device.
 14. The system of claim 11, further comprising anactuator that is movably attached to the catheter hub body to shift theflexible anchors from the non-deployed orientation to the deployedorientation.
 15. The system of claim 14, wherein the actuator includesan actuator rod that extends through an actuator channel defined insidethe catheter hub body and that is coupled with the anchor elements. 16.The anchor device of claim 15, wherein the actuator comprises a sliderinstrument that reciprocates along a portion of the first and secondproximal external lines at a location proximal of a proximal end of thecatheter hub body.
 17. The system of claim 16, further comprising alocking device to releasably maintain the pair of subcutaneous anchorelements in the deployed orientation, wherein the locking device ismovably connected to the slider instrument of the actuator.
 18. Thesystem of claim 17, wherein when the locking device is shifted to anactuator-locked position, the locking device limits movement of theactuator relative to the catheter hub body and hinders migration theflexible anchors from the deployed position toward the non-deployedposition.
 19. The system of claim 18, wherein the locking device isfriction fit between a proximal end of the catheter hub body and adistal facing surface of the actuator when the locking device is shiftedto the actuator-locked position.
 20. The system of claim 11, whereineach of the anchor elements extend from the catheter hub body in ancurved manner when in the deployed orientation, and wherein at least aportion of each anchor element exhibits superelasticity when shiftedfrom the non-deployed orientation to the deployed orientation.